Multichem Chloride Reagent S0933
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K874812 FDA 510(k)
- FDA Product Code
- CHJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1170 FDA 510(k)
- Regulation Number
- 862.1170 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Multichem Chloride Reagent S0933 is a mercuric thiocyanate reagent designed for colorimetric determination of chloride levels in clinical chemistry. It operates by reacting with chloride ions to produce a measurable color change, enabling quantitative analysis in laboratory settings.
This reagent is supplied as a single-use chemical solution for in vitro diagnostic use, classified under FDA regulation 21 CFR 862.1170 and assigned product code CHJ. It is intended for use in clinical chemistry laboratories and has received FDA 510(k) clearance (K874812) under the Traditional pathway, with a decision of Substantially Equivalent. No MRI safety or sterility specifications are indicated.
Frequently asked questions
What is the Multichem Chloride Reagent S0933 used for in a clinical setting?
The Multichem Chloride Reagent S0933 is specifically designed for the colorimetric determination of chloride levels in clinical chemistry. It reacts with chloride ions to produce a measurable color change, allowing laboratories to perform quantitative analysis of chloride concentrations in patient samples.
Is this reagent single-use or reusable, and how is it supplied?
The Multichem Chloride Reagent S0933 is supplied as a single-use chemical solution for in vitro diagnostic use. Each unit is intended for one-time use in clinical chemistry testing, ensuring consistency and avoiding cross-contamination.
Does this reagent require any special storage conditions, and is it sterile?
The provided data does not specify sterility requirements for the Multichem Chloride Reagent S0933, as it is a chemical reagent for laboratory analysis rather than a sterile medical device. Storage conditions are not detailed, but typical chemical reagents should be kept in a cool, dry place, protected from light and contamination, as per standard laboratory practices.
What regulatory pathway was followed for FDA clearance, and what classification does this device fall under?
The Multichem Chloride Reagent S0933 received FDA 510(k) clearance (K874812) under the Traditional pathway, determined to be Substantially Equivalent (SESE) to a predicate device. It is classified under FDA regulation 21 CFR 862.1170 and assigned the product code CHJ, placing it in Class II for clinical chemistry applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MULTICHEM CHLORIDE REAGENT S0933 (K874812) — FDA 510 (k) | Innolitics, MULTICHEM CHLORIDE REAGENT S0933 510 (k) K874812 - FDA.report, Multichem Chloride Reagent S0933 - Beudamed, PDF K874812 - Multichem Chloride Reagent S0933, Simmler, Inc. FDA 510 (k) Products (1980-1989)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K874812 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Simmler, Inc.
Sources (1)
- FDA 510(k) K874812 24 fields · synced Sep 18, 2026